Migraine is a common neurobiological disorder characterized by recurrent episodes of headache accompanied by sensory hypersensitivity, which can significantly impair quality of life. Acute treatments are used during a migraine attack with the objective to abort or reduce headache pain and restore normal function, while preventive treatments are intended to reduce attack frequency and severity.
Current acute migraine treatments are primarily pharmacologic approaches, with the most commonly used medications being analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and triptans. These drugs bear several contraindications and are associated with moderate to severe side effects. In patients with frequent and/or prolonged migraine attacks, excessive consumption of acute migraine drugs may lead to headache chronification and medication overuse headache, which portends a worse outcome. Moreover, some patients (particularly those with chronic migraine) may become resistant to conventional migraine medications and thus do not achieve sufficient pain relief. Medication-related adverse effects and limited effectiveness highlight the need for non-pharmacologic therapies.
Recent studies suggest that neurostimulation may be a promising modality for the treatment of headache disorders. Several neuromodulation technics have been investigated for the treatment of primary headaches. Pain Physician 11(2), 187-200 (2008) discloses open trials wherein percutaneous occipital nerve stimulation (p-ONS) was effective for chronic migraine. Lancet Neurology 6(4), 314-321 (2007) discloses the effectiveness of p-ONS for chronic cluster headache. Cephalalgia 31(3), 271-285 (2011) discloses positive results for p-ONS in a controlled study for chronic migraine. Cephalalgia 30(3), 260-271 (2010) discloses that a combined occipital nerve and supraorbital nerve neurostimulation shows better efficacy than occipital nerve stimulation alone. Neuromodulation 19(5), 507-514 (2016) discloses that while patient functional status is improved in the perioperative period, it waned over the long-term follow-up. Cephalalgia 33(10), 816-830 (2013) discloses that sphenopalatine ganglion stimulation (SPG) yields positive results in several trials mainly for the treatment of cluster headache. However, although generally well tolerated, these invasive neuromodulation technics could be appropriate for intractable migraine and chronic cluster headaches, but may not be acceptable for less severe migraine patient categories. Cephalalgia 36(6), 534-546 (2016) discloses that non-invasive vagus nerve stimulation shows clinical benefits beyond those with standard of care for cluster headache. However, the Journal of Headache and Pain 16, 63 (2015) and Neurology 87(5), 529-538 (2016) report negative results for non-invasive vagus nerve stimulation from sham-controlled trials for chronic migraine.
BMC Neurology 11, 135 (2011) discloses a double-blind, sham-controlled, cross-over study with healthy subjects in which transcutaneous supraorbital neurostimulation was found to produce a sedative effect. Neurology 80(8), 697-704 (2013) discloses a subsequent multi-center, randomized, double-blind, sham-controlled trial which reveals the efficacy and safety of external trigeminal nerve stimulation (e-TNS) for the prevention of episodic migraine. The Journal of Headache and Pain 16, 69 (2015) discloses a larger open randomized trial in which the therapeutic efficacy in migraine prevention was corroborated. The Journal of Headache and Pain 14, 95 (2013) discloses a prospective study of 2313 patients in which safety and patient satisfaction have been further confirmed.
However, there remains a need in the art for a safe non-drug and non-invasive acute treatment for migraine attacks.
US 2009/0 210 028 discloses a device for the electrotherapeutic treatment of headaches such as tension headaches and migraines. An electrode support has a shape and is size selected so as to allow, independently from the subject, the excitation of the afferent paths of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve. An electrical circuit includes a programmable signal generator suitable for creating pulses of a duration of between 150 and 450 μs with a maximum increase in intensity of 0 to 20 mA at a rate of less than or equal to 40 μA/s and with a step up in intensity not exceeding 50 μA.
US 2009/0 210 028 does not disclose the use of the device for the acute treatment of migraine attacks. In addition, US 2009/0 210 028 does not disclose particular treatment durations.
US 2010/0 274 327 discloses an electrotherapy system for stimulating sensory nerves within skin tissue. The system comprises an electrode carrier, a pulse generator, an array of skin-penetrating electrodes and surface skin electrodes, a pulse conditioning circuit, and a power source. The system administers biphasic pulsed current at the surface skin electrodes and monophasic pulsed current at each skin-penetrating electrode. The document in particular discloses the combined use of the skin-penetrating and surface skin electrodes. The embodiments disclosed in US 2010/0 274 327 provide an applicable electrode patch combining both the surface skin electrodes and skin-penetrating electrodes within this same patch. Non-invasive treatment is not possible with such an electrode patch. The system and in particular the surface skin electrodes are configured for masking pain due to stimulation via the skin-penetrating electrodes. The document does not disclose the treatment of migraine. The document also does not disclose the ophthalmic branch of the trigeminal nerve.
The present invention aims to resolve at least some of the problems mentioned above.